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  • No More Pen and Clipboard: Mobile, Paperless Management of Plant-Floor Data
    production workers who aren 't tethered to a computer at a fixed location. It not only does away with the old pen and clipboard used for data collection during rounds, it takes advantage of the multi-media capabilities of hand-held computers and smart phones to visually document and report conditions
  • Medical Device Link .
    . Each had labor-intensive procedures to track released documents and recall obsolete documents. Now most documents are generated and circulated as electronic files, usually in a wide variety of formats (e.g., text reports, technical drawings, flowcharts, scheduling tools, spreadsheets, and pictures
  • Medical Device Link .
    Technical Committee 210, Working Group (WG) 1, which drafted the document. But there are some caveats. �Canada has incorporated ISO 13485 directly
  • Brain Rein
    in Boston. ?It?s a way for companies to retain this information, document it and transfer it to somebody else.? For sure, knowledge management is a thriving business. Corporations have invested billions of dollars establishing processes and implementing technologies that enable them to leverage
  • Medical Device Link .
    . Validate too little and FDA will surely be dissatisfied. Identifying the right level of validation effort is the topic of a new technical information report (TIR) soon to be released by the Association for the Advancement of Medical Instrumentation (AAMI) Software Task Force. The document, "TIR
  • Documenting the Journey: Assembling a PAT Dossier
    on accuracy than format, on content than length, on insight than impression. As this industry travels toward a more scientifically-based destination, documents such as the PAT dossier will become the log of your technical journey. 1. FDA, "Guidance for Industry: PAT A Framework for Innovative
  • Medical Device Link . DESIGN CONTROLS
    for capturing design requirements and verifying and validating the design itself. Mandating such methods through regulation is the only way to ensure the uniform development of quality products. ISO 9000 standards, total quality management, and the FDA quality system regulation require that manufacturers

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